{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:21:48Z","timestamp":1791976908834,"version":"4.4.0"},"reference-count":27,"publisher":"American Medical Association (AMA)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"published-print":{"date-parts":[[2024,12,1]]},"abstract":"Importance<\/jats:title>Equecabtagene autoleucel (eque-cel), a fully human-derived B-cell maturation antigen-targeting chimeric antigen receptor (CAR) T-cell therapy, has exhibited potential for the treatment of relapsed or refractory multiple myeloma (RRMM), and further investigation in a larger cohort is necessary.<\/jats:p><\/jats:sec>Objective<\/jats:title>To evaluate whether eque-cel can benefit patients with RRMM and determine the overall response rate postinfusion.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>The FUMANBA-1 trial was a single-arm, open-label, phase 1b\/2 trial that evaluated eque-cel in adult patients with RRMM. Enrollment began in April 2020, and patients who received eque-cel will be monitored for a minimum of 15 years following the infusion. As of September 2022, patients with heavily pretreated RRMM who received at least 3 prior courses of therapy from 14 centers were enrolled. Data were analyzed from April 2020 to September 2022.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Patients received a single infusion of eque-cel at 1.0\u2009\u00d7\u2009106<\/jats:sup> CAR-positive T cells\/kg after the lymphodepletion.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Efficacy was the primary objective, and safety, pharmacokinetics, and pharmacodynamics were secondary objectives.<\/jats:p><\/jats:sec>Results<\/jats:title>Of 103 patients who received an eque-cel infusion, 55 (53.4%) were male, and the median (range) age was 58 (39-70) years. A total of 101 patients were evaluable for efficacy. At a median (range) follow-up of 13.8 (0.4-27.2) months, the overall response rate was 96.0% (97 of 101), with 74.3% (75 of 103) achieving a complete response or better. Among the 12 patients who had prior CAR T-cell treatment, 75% (9 of 12) achieved a response. The median progression-free survival was not reached, with a 12-month progression-free survival rate of 78.8% (95% CI, 68.6-86.0). A total of 96 patients (95.0%) achieved minimal residual disease negativity at a sensitivity threshold of 10\u22125<\/jats:sup>. Adverse events were favorable: 96 of 103 patients (93.2%) experienced cytokine release syndrome (grade 1 to 2 in 95 patients [92.3%]) and 2 (1.9%) experienced immune effector cell\u2013associated neurotoxicity syndrome (grade 1 to 2). All cases of immune effector cell\u2013associated neurotoxicity syndrome and 94 of 96 cases of cytokine release syndrome resolved with treatment. Additionally, only 20 patients (19.4%) developed antidrug antibodies. Cellular kinetic analysis confirmed CAR-positive T cells in all patients, with the longest duration at 735 days.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this trial, eque-cel led to early, deep, and durable responses in patients with heavily pretreated RRMM with a manageable safety profile. Patients with prior CAR T-cell therapy also benefitted from eque-cel.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>Chinese Clinical Trial Registry Identifier: ChiCTR2000033946<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamaoncol.2024.4879","type":"journal-article","created":{"date-parts":[[2024,11,7]],"date-time":"2024-11-07T16:31:48Z","timestamp":1730997108000},"page":"1681","source":"Crossref","is-referenced-by-count":28,"title":["Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma"],"prefix":"10.1001","volume":"10","author":[{"given":"Chunrui","family":"Li","sequence":"first","affiliation":[{"name":"Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China"},{"name":"Key Laboratory of Vascular Aging, Ministry of Education, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China"},{"name":"Immunotherapy Research Center 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China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Wang","sequence":"additional","affiliation":[{"name":"Nanjing IASO Medical Technology Co, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Songbai","family":"Cai","sequence":"additional","affiliation":[{"name":"Nanjing IASO Medical Technology Co, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianyong","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hematology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongping","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Hematology, the Affiliated Cancer Hospital of Zhengzhou University and the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 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